10 results
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22ms
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Sources: EU EUDAMED, US FDA
Falco Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918133201·Light handle cover_Soft_Non-sterile_1000ea/cs
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471142707·Ten-Ties, Purple
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383516501·"An absorbent paper points is an endodontic pap...
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMOOTHSHAPES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·August 10, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 15, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014